No Appeal in $8 Billion Verdict

The junk science-fueled, ready-fire-aim proclivity of the U.S. Food and Drug Administration has just cost the shareholders of pharmaceutical manufacturer American Home Products $8 billion.

A Texas jury recently awarded $23 million to a former user of the diet drug combination “fen-phen.” American Home Products, which made fenfluramine--the “fen” portion of fen-phen--has an excellent shot at a successful appeal. But the company’s shareholders are much less fortunate.

The verdict cost stockholders $8 billion in share value in one afternoon and cast a pall over the stock for the foreseeable future. And unlike the company, the stockholders have nowhere to appeal.

Unscrupulous personal injury lawyers operating in an unbridled tort system deserve much of the blame. But a great deal of fault lies, as it did with silicone breast implants, with the FDA.

A Case of Junk Science

The fen-phen saga began in July 1997, when the New England Journal of Medicine rushed to publish a Mayo Clinic report that 24 fen-phen users had heart valve damage. The report was not a scientific study, and only a few of the claimed cases of heart valve damage had been verified. While the Mayo report may have been grounds for further scientific investigation, the FDA reached for the “junk science” button instead.

The FDA sent “Dear Doctor” letters to physicians requesting information about heart valve disease among fen-phen users. A month later, the FDA had collected 92 reports of disease among 291 patients tested. Within days . . . and despite the availability of less drastic options . . . the FDA called for a halt in fen-phen use and “persuaded” drug-maker American Home Products to pull fenfluramine and another diet drug, Redux, from the market “voluntarily.”

There still was no scientific evidence against fen-phen--not even a controlled comparison of heart valve damage incidence among users and non-users of fen-phen. If there was a real and significant problem with fen-phen, one would have expected it to show up much earlier and in many more individuals--especially since the combination had been used for years by millions of people.

In 1992, the FDA’s unfounded moratorium on silicone breast implants led to a multibillion dollar shakedown of implant manufacturers. Similarly, the agency’s fen-phen actions opened the litigation floodgates. Personal injury lawyers trolled for fen-phen “victims,” and more than 3,100 lawsuits have been filed across the nation. Many more will no doubt be inspired by the Texas case, the first to reach a jury.

Two years afer the FDA’s panic, though, we still don’t know whether fen-phen caused any harm.

One recent scientific study reported no significant increase in heart valve problems among those who used fen-phen for less than six months. Another reported no increase in problems for those who took the drug combination for less than three months. The American Heart Association says it’s too soon to tell whether fen-phen caused significant damage to anyone and whether the effects wore off when use stopped.

And in the Texas case, the plaintiff’s own cardiologist testified that her heart problems pre-dated her use of fen-phen.

American Home Products: Episode One

Ironically, American Home Products’ last encounter with a federal agency’s junk science actually benefitted its shareholders.

A 1981 study by the National Institutes of Health reported that intrauterine birth control devices (IUDs) such as A.H. Robins Company’s Dalkon Shield increased the risk of pelvic infection by 60 percent. In addition to ending the use of IUDs in the U.S., the study spurred lawsuits that forced A.H. Robins into bankruptcy proceedings.

In 1991, the original data used in the NIH study were re-analyzed. A study published in the Journal of Clinical Epidemiology reported the NIH study “showed almost compete disregard for epidemiologic principles in its design, conduct, analysis, and interpretation of results.”

Unfortunately for A.H. Robins, the re-analysis came two years too late. In December 1989, American Home Products purchased A.H. Robins at a steep discount in what was then termed a “steal deal.”

When Will it End?

There is a solution to this madness. Oddly enough, the solution is being jeopardized by the same industry that has been victimized so badly.

A federal law enacted in October 1998 requires that the data generated by federally funded research be made available to the public through the Freedom of Information Act. The law is intended to facilitate independent review of the science used by federal agencies to support regulatory actions.

A.H. Robins might have survived the Dalkon Shield debacle if it had been given timely access to the NIH’s study data. When the FDA browbeat American Home Products into withdrawing fenfluramine from the market, the agency refused to provide the company with the original data gathered from its “Dear Doctor” letters. By denying the company an opportunity to challenge the “evidence” against it, the FDA rendered American Home Products virtually defenseless.

Though the new data access law appears to be a godsend, the pharmaceutical industry, including American Home Products, has worked to block its implementation, claiming the new law will compromise medical privacy and intellectual property rights.

The law will do nothing of the sort. Its purpose is limited and well-defined: ensuring that federal agencies don’t run amok with junk science. A recent study published by the Journal of Human and Veterinary Toxicology, using data gathered through a Freedom of Information Act request, proved the National Cancer Institute’s jihad against the widely used lawn herbicide 2,4-D to be without scientific basis.

American Home Products’ shareholders may well be asking why the company doesn’t support data access . . . and why it didn’t support this solution $8 billion ago.